| | | From the Atlantic article:
Abbott’s test itself is not quite the fulfillment of that grand vision, though—at least not yet. Michael Mina, a Harvard epidemiologist who has pushed for the deployment of this kind of rapid test, was not ready to declare that the new era had begun. “This is the type of test that we’ve been waiting for, but may not be the test,” Mina told me.
The fine details of the FDA’s emergency use authorization, the regulatory sign-off that allows a test to be sold, are significant. Antigen tests such as this one detect viral protein and are less sensitive than the gold-standard PCR tests, which detect viral RNA. So, to gain acceptance, Abbott showed data confirming that its test was able to classify a pool of samples in nearly the same way as PCR tests of the same samples. Although its performance was impressive, the number of samples was far smaller than would be tested under normal circumstances—just 102.
I am little surprised that the FDA would issue an emergency use authorization with such a small number of samples. |
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